8ch Foot Ankle Coil

K160935 · Shenzhen RF Tech Co., Ltd. · MOS · Jul 28, 2016 · Radiology

Device Facts

• Record ID: K160935
• Device Name: 8ch Foot Ankle Coil
• Applicant: Shenzhen RF Tech Co., Ltd.
• Product Code: MOS · Radiology
• Decision Date: Jul 28, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

8ch Foot Ankle Coil manufactured by RFT is a receive-only RF surface coil designed for use with GE 1.5T MRI systems. 8ch Foot Ankle Coil is indicated to use for foot and ankle imaging. The nucleus excited is hydrogen.

Device Story

8ch Foot Ankle Coil is a receive-only RF surface coil for GE 1.5T MRI systems; captures hydrogen proton signals from patient foot/ankle anatomy. Device consists of 8 phased array coil elements with integrated preamplifiers; optimized for parallel imaging. Used in clinical MRI settings; operated by MRI technicians/radiologists. Coil conforms to patient anatomy to minimize discomfort; includes base plate for positioning. Output is raw RF signal processed by the host MRI system to generate diagnostic images. Benefits include high-quality imaging of foot/ankle structures for clinical diagnosis.

Clinical Evidence

No clinical trials performed. Evidence consists of bench testing (biocompatibility, IEC 60601-1/1-2, B1 peak, NEMA signal-to-noise ratio/uniformity, blocking network analysis, surface temperature) and sample clinical images acquired across compatible GE 1.5T MRI systems to demonstrate diagnostic utility.

Technological Characteristics

8-channel phased array RF receive-only coil; integrated preamplifiers; RF chokes with switching diodes for decoupling. Compatible with GE 1.5T MRI systems via p-port connector. Tested per IEC 60601-1, IEC 60601-1-2, and NEMA standards for MRI coil performance.

Indications for Use

Indicated for foot and ankle imaging in patients undergoing MRI procedures using GE 1.5T MRI systems.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• GE 8CH Foot Ankle Coil (K122694)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Shenzhen RF Tech Co., Ltd. % Mr. Ke Xi CEO 2-f, Bld4, Juhui Industrial Park, Tianliao, Guangming Shenzhen, Guangdong 518132 CHINA

Re: K160935

Trade/Device Name: 8ch Foot Ankle Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: June 30, 2016 Received: July 1, 2016

Dear Mr. Xi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

July 28, 2016

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Page 2-Mr. Ke Xi

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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| Form Approved: OMB No. 0910-0120 |
|-----------------------------------|
| Expiration Date: January 31, 2017 |
| See PRA Statement on last page. |

| 510(k) Number (if known) | K160935 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Device Name | 8ch Foot Ankle Coil |
| Indications for Use (Describe) | 8ch Foot Ankle Coil manufactured by RFT is a receive-only RF surface coil designed for use with GE 1.5T MRI systems. 8ch Foot |

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use产 ्। ្រ

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Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☑</span> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">□</span> |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

| FOR FDA USE ONLY |
|------------------|
|------------------|

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

PSC Publishing Services [phone] EFF

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Image /page/4/Picture/0 description: The image shows a logo with the letters "RFT" in bold, dark blue font, enclosed within a blue oval. A small orange diamond is positioned between the "R" and the "T". Below the logo, the text "510(k) Summary" is written in a bold, black font. The text is centered below the logo.

In accordance with 21 CFR 807.92 the following summary of information is provided:

l. Submitter

Shenzhen RF Tech Co., Ltd

2-F, Bld4, Juhui Industrial Park, Tianliao, Guangming, Shenzhen, 518132 China

Phone: [phone]

Fax: [phone]

| Contact Person: | Mr. Ke Xi |
|-----------------|---------------------------|
| | CEO |
| | Shenzhen RF Tech Co., Ltd |
| | Email: [e-mail] |
| Date Prepared: | March 31, 2016 |

- II. Device

| Name of Device: | 8ch Foot Ankle Coil |
|-----------------------|-----------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Coil, Magnetic Resonance, Specialty |
| Classification Names: | Magnetic resonance diagnostic device (21 CFR 892.1000) |
| Regulation Class: | II |
| Product Code: | MOS |
| Model: | RFT Model Number: 10-F23936<br>This device is manufactured by RFT and distributed by GE Medical<br>Systems, LLC |

III. Predicate Device

Predicate device: K122694, GE 8CH Foot Ankle Coil;

#### IV. Device Description

The 8ch Foot Ankle Coil is a surface coil used for Magnetic Resonance Imaging. It's tuned to image Proton nuclei in a receive-only configuration. It is comprised of 8 individual Phased Array coil elements which receive the signal from patient's foot or ankle. Preamplifiers are integrated in the coil. The geometry is optimized for use with parallel imaging techniques.

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Image /page/5/Picture/0 description: The image shows a logo with the letters "RFT" in bold, blue font. The letters are enclosed in a blue oval. There is a small orange diamond between the "F" and "T". The logo appears to be for a company or organization with the initials RFT.

Traditional 510(k) Submission 8ch Foot Ankle Coil

The 8ch Foot Ankle Coil comprises the coil and the base plate. The coil conforms to patients' anatomy, accommodating various foot contours while minimizing patient discomfort. The base plated from the coil part is used to place the patients' anatomy on the table.

#### V. Intended Use

8ch Foot Ankle Coil manufactured by RFT is a receive-only RF surface coil designed for use with GE 1.5T MRI systems. 8ch Foot Ankle Coil is indicated to use for foot and ankle imaging. The nucleus excited is hydrogen.

#### VI. COMPATIBILITY

The connector of 8ch Foot Ankle Coil is p-port. The 1.5T 8ch Foot Ankle Coil is compatible with GE 1.5T MRI systems where coil ID allows.

For example: GE SIGNA Voyager 1.5T system GE Optima MR450W 1.5T system GE Discovery MR450 1.5T system

#### VII. Technology

8ch Foot Ankle Coil is 8-channel phased array RF receive only coils with integrated preamplifiers. The coil designs consist of RF chokes with switching diodes to provide decoupling which isolates the coil elements from RF fields during RF transmission. This coil is designed based on the same technology as the predicate device.

- VIII. Determination of Substantial Equivalence
## Summary of Non-Clinical Tests:

Verification testing has been performed and is documented in the sections noted below of this submission. The following verification tests have been performed:

- 1. Biocompatibility testing (Section 15)
- 2. IEC 60601-1-2 testing (Section 17)
- 3. IEC 60601-1 testing (Section 17)
- 4. Maximum B1 Peak test (section 18)

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Image /page/6/Picture/0 description: The image shows a logo with the letters "RFT" in bold, blue font. The letter "F" has a small orange square in the middle. The letters are enclosed in a blue oval shape. The logo appears to be for a company or organization with the initials RFT.

Traditional 510(k) Submission 8ch Foot Ankle Coil

- Signal to Noise ratio and uniformity test according to NEMA standard (section 18) 5.
- 6. Blocking Network analysis (section 18)
- 7. Surface temperature test normal condition (section 18)
- 8. Surface temperature test unplugged condition (section 18)

### Summary of Clinical Tests:

Sample clinical images included in Section 20 were performed with all compatible GE 1.5T MRI systems. All sample clinical images are provided in all three imaging planes.

#### IX. Conclusion

Shenzhen RF Tech Co., Ltd considers the 8ch Foot Ankle Coil does not raise any new issues of safety or effectiveness, and performs as well as the legally marketed predicate device.